ANDA Parking & MA Holding
ANDA parking and marketing-authorization holding services for partners without a local presence.
Overview
Companies often hold approved ANDAs or marketing authorizations they cannot or do not wish to commercialize directly — dormant assets that still carry obligations and still represent value. Others need a holder in a market where they have no entity. PharmExpert provides ANDA parking and MA holding services that keep these assets compliant and commercially available.
An approved ANDA or authorization does not maintain itself; it carries ongoing regulatory and pharmacovigilance obligations that, if neglected, put the asset's good standing at risk. We hold or arrange holding and keep those obligations current, so the asset stays viable.
Holding is paired with monetization. We help identify partners and structure arrangements to commercialize or out-license the asset, turning something dormant into a source of value rather than a standing liability.
Throughout, we provide compliance oversight of the held assets and coordinate the pharmacovigilance obligations through our PV pillar. The result is regulatory assets kept compliant, available, and working for you rather than sitting idle.
What we do
- ANDA parking and management
- Marketing-authorization holding (where permitted)
- Maintenance of regulatory and PV obligations
- Partner identification for monetization
- Transfer and onboarding support
- Compliance oversight of held assets
Our process
- 1
Assess
Review the assets, markets and obligations.
- 2
Structure
Define the parking / holding arrangement.
- 3
Hold
Maintain obligations and compliance.
- 4
Monetize
Support partnering and value realization.
What you receive
- Parking / holding arrangement
- Obligation-maintenance plan
- Partnering support
- Compliance oversight
Who needs this
Companies with dormant ANDAs/MAs, organizations needing a holder without a local entity, and teams monetizing regulatory assets.
Frequently asked questions
Ready to improve your compliance?
Talk to an independent PharmExpert specialist about your GxP, regulatory or quality challenge. We respond within one business day.